北京市海淀区128例新生儿10μg重组乙肝疫苗初免后5年免疫效果观察

Efficacy of 10 μg recombinant hepatitis B vaccine in 128 infants 5 years after primary vaccination series in Haidian district of Beijing

目的评价北京市海淀区128例新生儿全程接种10μg重组乙型肝炎(乙肝)疫苗(HepB)后5年免疫效果。方法选取按照北京市免疫程序0、1和6月龄完成3剂10μg重组HepB、并于7~12月龄完成初免效果调查的儿童128人,于初免后5 a采集静脉血标本5 ml,检测乙肝表面抗体(抗-HBs)、乙肝表面抗原(HBsAg)和乙肝核心抗体(抗-HBc)。采用χ2和t检验对不同特征儿童抗-HBs阳性率和常用对数转换后的平均几何浓度(GMCs)进行比较,初免后5 a抗-HBs阳性率影响因素分析采用非条件多因素logistic回归模型。结果新生儿完成10μg重组HepB初免后5 a,无HBsAg阳性出现,抗-HBc阳性率为0.78%。抗-HBs阳性率为75.00%,抗-HBs GMCs为27.16 m U/ml,低于HepB初免后抗-HBs阳性率(100%)和GMCs(1 628.17 m U/ml),差异有统计学意义(χ_(配对)~2=30.031,P<0.01;t_(配对)=36.077,P<0.01)。多因素logistic回归模型分析显示,HepB初免后5 a抗-HBs阳性率与初免后抗-HBs高应答有关(OR=9.210,95%CI:3.539~23.972;P<0.01)。结论新生儿10μg重组HepB初免后5 a免疫效果较好,虽然抗-HBs阳性率和抗-HBs GMCs随时间下降,但仍然维持在较高的水平。

[Objective]To assess the efficacy of 10 μg recombinant hepatitis B（HepB） vaccine in 128 infants 5 years after 3-dose primary vaccination series in Haidian district of Beijing.[Methods]A total of 128 children, who were respectively vaccinated 3 doses of 10μg hepatitis B vaccine at 0,1 and 6 months of age,and received the primary vaccination effect investigation at 7-12 months old,were enrolled in the study. Venous blood sample（5 ml） was collected 5 years after primary vaccination,to test the antibody to hepatitis B surface antigen（anti-HBs）,hepatitis B surface antigen（HBsAg）,and antibody to hepatitis B core antigen（anti-HBc）. Chi-squared test and t test was used to compare the positive rate of anti-HBs and geometric mean antibody concentrations（GMCs） among children with different characteristics. A multiple logistic regression model was used to obtain the factors influencing the positive rate of anti-HBs 5 years after primary vaccination.[Results]5 years after primary vaccination with 10 μg recombinant hepatitis B vaccine,there was no positive case of HBsAg,and positive rate of antiHBc was 0.78%. The positive rate of anti-HBs was 75.00% and GMCs was 27.16 m U/ml,which was lower than that after primary vaccination（positive rate of anti-HBs was 100% and GMCs was 1 628.17 m U/ml）,and the differences were statistically significant（χpaired^2=30.031,P〈0.01;tpaired=36.077,P〈0.01）. The multiple logistic regression model showed that the positive rate of anti-HBs 5 years after primary vaccination was associated with high anti-HBs concentration levels after primary vaccination（OR=9.210,95%CI：3.539~23.972,P〈0.01）.[Conclusion]The efficacy of 10 μg recombinant HepB vaccine in newborns 5 years after primary vaccination series is satisfactory. Though the positive rate and GMCs of anti-HBs have declined over time,they still remain at high levels..